{"schema_version":"secwatch.filing_event.v1","accession":"0001493152-26-043051","form_type":"8-K","ticker":"MIRA","cik":"0001904286","company_name":"MIRA PHARMACEUTICALS, INC.","filed_at":"2026-09-17T12:30:40+00:00","discovered_at":"2026-09-17T12:35:01.516859+00:00","generated_at":"2026-09-17T12:35:12.195790+00:00","sec_items":["7.01","9.01"],"event_type":"other_material","sentiment":"positive","materiality_score":0.5,"calibrated_materiality_score":0.5,"confidence":"high","headline":"MIRA advances Ketamir-2 Phase 2a for CIPN; IRB submission after FDA review, site initiation targeted Q1 2027","bullets":["Phase 2a protocol for Ketamir-2 in CIPN submitted for IRB review after incorporating FDA feedback; site initiation targeted Q1 2027.","Randomized, double-blind, placebo-controlled three-period crossover; Ketamir-2 300 mg and 600 mg vs placebo; 7-day periods with 13-day washouts.","Builds on completed Phase 1 in healthy volunteers with favorable safety/PK profile; no serious adverse events or dose-limiting toxicities.","No FDA-approved therapies specifically indicated for CIPN; Ketamir-2 is not a DEA-controlled substance.","MIRA to present Ketamir-2 data at Tokyo conference Oct 5-6, 2026 and attend BioJapan for licensing discussions."],"urls":{"canonical":"https://secwatch.observer/filing/0001493152-26-043051","json":"https://secwatch.observer/filing/0001493152-26-043051.json","markdown":"https://secwatch.observer/filing/0001493152-26-043051.md","text":"https://secwatch.observer/filing/0001493152-26-043051.txt","edgar_index":"https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/0001493152-26-043051-index.htm","edgar_primary_document":"https://www.sec.gov/Archives/edgar/data/1904286/000149315226043051/form8-k.htm"},"model":{"generated_by":"deepseek-v4-flash:cloud@v2","generated_at":"2026-09-17T12:35:12.195790+00:00"},"review":{"review_status":"machine_generated","human_reviewed":false,"corrected":false,"correction_note":null,"correction_timestamp":null,"superseded_by":null,"related_filings":[]},"source_grounded_claims":[],"license":"Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer"}